Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07694609

Integrated Clinical-Occupational Management for Workers With Chronic Noncommunicable Diseases

MCNT@WORK is a prospective multicenter observational study assessing how chronic noncommunicable diseases affect work ability, quality of life, psychological well-being, and occupational participation. It will enroll at least 200 working-age adults with inflammatory bowel disease or breast cancer, assessed at baseline and after 12 months. The study will collect clinical, functional, psychological, social, and occupational data to identify factors linked to reduced work ability, absenteeism, presenteeism, return-to-work barriers, or early labor-market exit. Findings will support an integrated clinical-occupational care pathway, combining specialist care and occupational medicine. The goal is to promote personalized support, safe return to work, job retention, and sustainable employment.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, RM, Italy

Loading trial locations.

About this study

MCNT@WORK is a prospective, multicenter observational study designed to evaluate the impact of chronic noncommunicable diseases on work ability, quality of life, psychological well-being, and occupational participation in working-age adults. The study will enroll at least 200 adult participants, including 100 patients with inflammatory bowel diseases, defined as Crohn's disease or ulcerative colitis, and 100 patients with breast cancer. Participants will be recruited from the participating clinical units and will undergo a baseline assessment at enrollment and a follow-up assessment after 12 months. At baseline, the study will collect integrated socio-demographic, clinical, functional, psychological, and occupational information. The assessment will include disease-related characteristics, treatments, functional limitations, work status, job characteristics, occupational exposures or work-related risks, perceived work limitations, quality of life, fatigue, perceived stress, anxiety, depression, work ability, work participation, absenteeism, presenteeism, and productivity. The same domains will be reassessed at 12 months in order to describe changes over time and to identify clinical, psychological, social, and occupational factors associated with reduced work ability, impaired well-being, work absence, barriers to return to work, or risk of early exit from the labor market. The study addresses two chronic disease populations in which work participation may be affected by disease activity, treatment burden, fatigue, psychological distress, functional limitations, and workplace-related factors. For patients with inflammatory bowel disease, the study will consider the impact of disease symptoms, disease activity, extraintestinal manifestations, treatment pathways, and quality of life on work functioning. For patients with breast cancer, the study will explore the occupational impact of diagnosis, surgery, systemic treatments, fatigue, upper-limb morbidity, psychological burden, and the process of return to work during or after treatment.

Based on the multidimensional assessment, the study aims to develop and implement an integrated clinical-occupational management pathway for workers with chronic diseases. This pathway will combine specialist clinical care and occupational medicine and may include lifestyle counseling, psychological support, evidence-based non-pharmacological strategies, social prescribing, workplace health and safety recommendations, reasonable accommodations, job or task adaptations, and strategies to support job retention or return to work. The study will also support the development of practical tools for multidisciplinary assessment and management, such as integrated clinical-occupational evaluation forms, operational checklists, decision-support pathways, and recommendations for personalized risk management. These tools are intended to help clinicians, occupational physicians, and other stakeholders identify work-related needs, define appropriate support measures, and promote safe and sustainable employment.

The overall goal of the study is to generate evidence and operational recommendations for a personalized, multidisciplinary approach to the management of workers with inflammatory bowel disease or breast cancer. By integrating clinical, psychological, social, and occupational dimensions, MCNT@WORK aims to support global health, quality of life, work ability, work participation, job retention, and safe return to work among people living with chronic diseases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years and <70 years.
  • Confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis, or confirmed diagnosis of breast cancer.
  • Patient under care at one of the participating clinical units.
  • For patients with breast cancer: inclusion from diagnosis, during preparation for surgery or neoadjuvant chemotherapy, or during post-treatment follow-up.
  • For patients with inflammatory bowel disease: confirmed diagnosis at any clinical stage and regardless of ongoing treatment.
  • Ability to understand the aims of the study and to complete the questionnaires required by the protocol.
  • Written informed consent to participate in the study and to the processing of personal data according to Regulation (EU) 2016/679 - GDPR.

Exclusion criteria

  • Age <18 years or >70 years.
  • Absence of a confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis, or breast cancer.
  • Acute clinical conditions or severe comorbidities that, in the opinion of the responsible physician, prevent participation in the study or correct completion of the assessment tools.
  • Cognitive, linguistic, or psychiatric impairment affecting the ability to understand the information provided or to complete the questionnaires required by the protocol.
  • Failure to provide written informed consent or refusal of personal data processing according to Regulation (EU) 2016/679 - GDPR.

Treatment and study plan

Primary outcomes

  1. Change in Work Ability Index (WAI) Score From Baseline to 12 Months

    Time frame: Baseline and 12 months

    Work ability will be assessed using the Work Ability Index (WAI), a standardized and validated questionnaire evaluating the worker's perceived ability to work in relation to job demands, health status, diagnosed diseases, sickness absence, future work ability expectations, and psychological resources. The total WAI score ranges from 7 to 49, with higher scores indicating better work ability. Change in WAI score will be assessed by comparing baseline values with values collected at the 12-month follow-up.

Secondary outcomes

  1. Change in Inflammatory Bowel Disease Activity From Baseline to 12 Months

    Time frame: Baseline and 12 months

    Disease activity in participants with inflammatory bowel disease will be assessed using validated clinical indices. Crohn's disease activity will be evaluated using the Crohn's Disease Activity Index (CDAI), which combines patient-reported symptoms, clinical findings, and laboratory parameters collected over 7 days. The CDAI score generally ranges from 0 to 600, with higher scores indicating greater disease activity. Ulcerative colitis activity will be evaluated using the Mayo Score, which includes stool frequency, rectal bleeding, endoscopic findings, and physician global assessment. The Mayo Score ranges from 0 to 12, with higher scores indicating greater inflammatory activity.

  2. Breast Cancer Clinical and Pathological Profile

    Time frame: Baseline and 12 months

    The clinical and pathological profile of participants with breast cancer will be described using tumor staging, histological grading, and molecular classification. Tumor stage will be assessed according to the TNM classification, which evaluates tumor size and local extension, regional lymph node involvement, and distant metastases. Histological grading will be assessed using the Nottingham system, based on tubular formation, nuclear pleomorphism, and mitotic index. Molecular classification will be based on biological markers including estrogen receptor, progesterone receptor, HER2 status, and Ki-67, allowing classification into clinically relevant breast cancer subtypes.

  3. Change in Functioning, Disability, and Work Participation From Baseline to 12 Months

    Time frame: Baseline and 12 months

    Functioning, disability, and work participation will be assessed using the International Classification of Functioning, Disability and Health (ICF). The ICF provides a multidimensional framework to describe body functions and structures, activities and participation, and contextual factors, including environmental and personal factors. In this study, the ICF will be used to identify functional limitations, restrictions in work-related activities, and environmental barriers or facilitators relevant to job retention and return to work.

  4. Change in Work Productivity and Activity Impairment From Baseline to 12 Months

    Time frame: Baseline and 12 months

    Work productivity and activity impairment will be assessed using the Work Productivity and Activity Impairment Questionnaire (WPAI). The WPAI-General Health version will be used for participants with breast cancer, while the WPAI-Specific Health Problem version will be used for participants with inflammatory bowel disease. The WPAI evaluates employment status, hours missed from work, hours worked, impairment while working, overall work productivity loss, and activity impairment over the previous 7 days. Results are expressed as percentages, with higher values indicating greater impairment.

  5. Change in Worker Well-Being From Baseline to 12 Months

    Time frame: Baseline and 12 months

    Worker well-being will be assessed using the NIOSH Worker Well-Being Questionnaire (NIOSH WellBQ), in the validated Italian version. The questionnaire evaluates worker well-being from a holistic perspective across five domains: work evaluation and experience, workplace policies and culture, workplace physical environment and safety climate, health status, and home, community, and society. The instrument includes 126 items and provides domain-specific indices and scales; it does not provide clinical diagnostic cut-offs.

  6. Change in Health-Related Quality of Life From Baseline to 12 Months

    Time frame: Baseline and 12 months

    Health-related quality of life will be assessed using the Medical Outcomes Study Short Form-36 Health Survey (SF-36). The SF-36 is a 36-item self-administered questionnaire assessing eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores are transformed on a 0 to 100 scale, with higher scores indicating better perceived quality of life. Physical and mental component summary scores may also be calculated.

  7. Change in Depression, Anxiety, and Stress Symptoms From Baseline to 12 Months

    Time frame: Baseline and 12 months

    Depression, anxiety, and stress symptoms will be assessed using the Depression Anxiety Stress Scales-21 items (DASS-21). The DASS-21 is a self-report psychometric instrument composed of 21 items divided into three 7-item subscales assessing depression, anxiety, and stress. Each item is rated on a 4-point Likert scale according to symptom frequency during the previous week, with higher scores indicating greater symptom severity.

  8. Change in Psychological Well-Being From Baseline to 12 Months

    Time frame: Baseline and 12 months

    Psychological well-being will be assessed using the Psychological General Well-Being Index (PGWBI). The PGWBI is a 22-item questionnaire evaluating perceived emotional and psychological well-being over the previous 4 weeks. It includes six dimensions: anxiety, depression, positive well-being, self-control, general health, and vitality. The total score ranges from 0 to 110, with higher scores indicating better psychological well-being

  9. Change in Fatigue From Baseline to 12 Months

    Time frame: Baseline and 12 months

    Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue is a standardized and validated 13-item patient-reported outcome measure evaluating fatigue intensity, energy level, ability to perform daily, work, and social activities, and the impact of fatigue on physical and psychological well-being during the previous 7 days. The total score ranges from 0 to 52, with higher scores indicating lower fatigue severity and better global functioning.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Evaluation of an Integrated Clinical-Occupational Management Pathway for the Global Health Protection of Workers With Chronic Noncommunicable Diseases

Acronym: MCNT@WORK

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.